(198 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set for in the Professional Instructions for Use.
da Vinci Table Motion is intended to allow the surgical staff to reposition the patient by adjusting the table without undocking the da Vinci Xi Surgical System during urologic surgical procedures, general laparoscopic surgical procedures, and gynecologic laparoscopic surgical procedures. It is designed to be used with a compatible OR table.
da Vinci Table Motion is a software-enabled feature for the da Vinci Xi Surgical System. da Vinci Table Motion allows the surgical team to reposition the patient by adjusting the operating table synchronously with, but without undocking from, the Xi surgical system. Communication between the system and the table is established through IR and RF wireless signals. There is also a wired configuration if wireless is not available.
All motion commands entered by the user on the table remote control are re-directed through the da Vinci Xi system for authorization. When paired, all table remote control button presses. instead of being sent directly from the remote control to the table motion controller in the table, are forwarded to the da Vinci Xi for approval. When the da Vinci Xi determines that the system is in a safe state for table motion to occur, the button request is forwarded to the table motion controller, and motion may then occur.
To enter da Vinci Table Motion, all instrument tips must be in view and under active control by the surgeon at the console; instruments not under active surgeon control must be removed and the table feet must be locked before the system will allow table motion.
During Table Motion, the da Vinci Xi system monitors the positioning and velocity of the Trumpf Medical TS7000dV Operating Room Table. The setup joint (SUJ) brakes release and allow the arms to passively follow table movements. The setup structure and boom actively move with the table as needed to maintain relative positioning of the remote center of each arm.
Audio and visual messaging is used to guide the user during table motion. Audio cues consist of tones and voice prompts. Visual messaging on the surgeon display, vision cart touchscreen, and table remote control, informs users of table motion status. The vision cart touchscreen display includes a tabbed interface that allows the user to adjust certain system settings, view and recover from system fault conditions, and view instructions.
The document describes the da Vinci Xi Surgical System with Table Motion. The acceptance criteria and the study proving it meets these criteria are outlined primarily in the "Performance Data" and "Human Factors and Usability Testing" sections.
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1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome Desired | Reported Device Performance |
|---|---|---|
| Software Functionality | User interface, algorithm, and software verification. | Software testing included user interface, algorithm, and software verification testing. No specific performance metrics are given beyond stating it "passed." |
| Electrical Safety & EMC | Conformance to recognized standards for electrical safety and electromagnetic compatibility. | Electrical safety and EMC testing were conducted by outside labs and in conformance to recognized standards. |
| Clinical Performance (Safety) | At least as safe as the current manual method of table motion. No issues of safety or effectiveness identified. Residual risk at acceptable levels. Use-safety not diminished compared to non-integrated process. | - Porcine model assessment: the IOTM method is "at least as safe as the current manual method of table motion." |
- Successfully passed all test cases in design validation testing, identifying "no issues of safety or effectiveness and no new risks."
- Surgeon evaluators scored the safety of performing surgery using IOTM at a Likert score of 3 or above (passing).
- Human factors testing concluded "residual risk is at acceptable levels, and that the use-safety of the system has not diminished." |
| Clinical Performance (Efficacy/Functionality) | Clinically acceptable performance for urologic, general laparoscopic, and gynecologic laparoscopic procedures (corresponding to indications for use). Ability to complete surgical procedures, adequately expose tissues/organs, and maintain adequate external clearance while using IOTM. | - Clinical validation testing demonstrated "clinically acceptable performance." - Surgeon evaluators confirmed the ability to complete surgical procedures, adequately expose tissues and organs, and maintain adequate external clearance while using IOTM with an average Likert score of 4.7 or higher. |
| Usability/Human Factors | Low user error rate, acceptable user experience. Safe and effective when used by intended users in the intended use environment. | - Summative usability validation studies involved typical workflow and troubleshooting scenarios. - Objective data included observations of users' ability to complete tasks, use-errors, close calls, and difficulties. Subjective feedback collected.
- Results provided evidence that the system is "safe and effective when used by the intended users in the intended use environment." (No specific metric provided for "low user error rate" but implied by "safe and effective"). |
| Design Validation | Successful completion of all test cases (pairing & basic functionality, intraoperative table motion, surgical performance, foreseeable clinical misuse, egress and transport, user interactions). | The da Vinci Xi Surgical System with Table Motion "successfully passed all test cases" in design validation testing. |
| Substantial Equivalence | Demonstrates substantial equivalence to the predicate device (da Vinci Xi Surgical System, K131861). | Performance data demonstrated the subject device is "substantially equivalent to the predicate device." Final summary states this device "is substantially equivalent" based on all data. |
2. Sample Size Used for the Test Set and Data Provenance
- Design Validation Testing (Clinical Engineers):
- Sample Size: One porcine model, one cadaver, and various dry/inanimate models.
- Data Provenance: Not explicitly stated, but implies animal, cadaver, and inanimate models used in a lab setting ("across three labs"). This is prospective testing on models.
- Surgeon Evaluation Testing:
- Sample Size: Porcine model (number not specified), cadaver model (number not specified).
- Data Provenance: Not explicitly stated, but implies animal and cadaver models used in a lab setting ("across six labs"). This is prospective testing on live and cadaveric models.
- Human Factors and Usability Testing:
- Sample Size: A minimum of fifteen surgical teams participated in each of the two summative usability validation studies (total of at least 30 teams). Each team comprised a surgeon, operating room staff, and an anesthesiologist.
- Data Provenance: Simulated OR environment, implying prospective data collection in a controlled lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Design Validation Testing (Clinical Engineers): Performed by "clinical engineers." No specific number or further qualifications are given.
- Surgeon Evaluation Testing: Six independent, external surgeons.
- Qualifications: Representing four different surgical specialties: Gynecological Oncology, Urology, Colorectal, and General Surgery. No specific experience level (e.g., "10 years of experience") is provided.
- Human Factors and Usability Testing: Users included "surgeons, operating room staff, and anesthesiologists."
- Qualifications: Surgeons from different surgical specialties (urology, gynecology, general surgery, and colorectal). No specific experience level is provided.
4. Adjudication Method for the Test Set
The document does not describe a formal "adjudication method" in the sense of resolving disagreements among experts to establish ground truth.
- For the Surgeon Evaluation Testing, surgeons provided individual Likert scores. The reporting focuses on the collective "average Likert score," suggesting individual evaluations were aggregated rather than adjudicated to reach a singular "ground truth" per case. They all "found that the IOTM method is at least as safe" and confirmed the abilities.
- For Human Factors and Usability Testing, objective performance data (observations of task completion, use-errors, close calls) and subjective feedback were collected. This was aggregated to assess overall usability and safety.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
Yes, a form of comparative effectiveness study was done in the "Surgeon Evaluation Testing."
- Comparison: The IOTM method (subject device) was compared against the "current manual method of table motion."
- Effect Size (Improvement):
- Safety: Surgeons found the IOTM method "is at least as safe" as the manual method. While not a quantitative improvement, it demonstrates non-inferiority in safety.
- Efficacy/Functionality: For the ability to complete surgical procedures, adequately expose tissues and organs, and maintain adequate external clearance, surgeons yielded an average Likert score of 4.7 or higher. The Likert scale was 1-5, where 3 was considered passing. This suggests a strong positive assessment of the IOTM method's functionality, though a direct "improvement effect size" against the manual method (e.g., "human readers improve X% with AI") is not quantitatively provided in this context. The manual method's Likert score is not given for comparison, only that the IOTM passed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device is an "Endoscopic Instrument Control System" that integrates "Table Motion" functionality. This isn't an AI diagnostic algorithm, but rather a system that assists surgical teams. The evaluation inherently involves a human-in-the-loop (surgeon, OR staff) as the device's function is to assist surgical procedures. Therefore, a "standalone algorithm only" performance study in the typical sense of AI diagnostics would not be applicable or described here. The "software testing" mentioned would be an internal, component-level evaluation, not a clinical standalone performance.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's performance evolved based on the type of testing:
- Design Validation Testing: Likely engineering specifications, design input requirements, and safety/effectiveness goals defined by the manufacturer, evaluated by clinical engineers. "Successful passing of all test cases" against these internal criteria serves as the ground truth.
- Surgeon Evaluation Testing: Expert consensus/judgment by the six independent surgeons was the primary ground truth. Their Likert scores and qualitative assessment of safety and ability to perform tasks formed the basis.
- Human Factors and Usability Testing: A combination of objective observation of user performance (e.g., successful task completion, presence/absence of errors) against pre-defined success criteria, and subjective expert feedback from the surgical teams, served as ground truth for usability and use-related risks.
8. The Sample Size for the Training Set
This document describes a 510(k) submission for a surgical system with a new feature (Table Motion). It is not an AI/ML device in the sense that it relies on a "training set" to learn and perform a task (e.g., classify images). The "Table Motion" feature is a software-enabled control system.
Therefore, the concept of a "training set" as understood in machine learning is not applicable here and is not mentioned or described in the document. The system is designed and tested against specifications rather than 'trained' on data.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" is not applicable to this device and its evaluation as described.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.